High-grade Cervical Intraepithelial Neoplasia
Conditions
Interventions
Trade Name: Aldara
Product Name: Imiquimod
Pharmaceutical Form: Cream
INN or Proposed INN: IMIQUIMOD
CAS Number: 99011-02-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Maastricht University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - de novo CIN2 or CIN3 lesion, histologically confirmed by diagnostic biopsy - age of 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - previous histologically confirmed high-grade CIN (CIN 2–3) - concomitant vulvar and/or vaginal intraepithelial neoplasia - previous cervical malignancy - current malignant disease - immunodeficiency (including HIV/AIDS and immunodepressive medication) - pregnancy or lactation - legal incapability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objectives: - To investigate the efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions, compared to LLETZ treatment, in selected populations - To develop a prediction model for the efficacy of imiquimod treatment in the individual patient, based on biomarkers reflecting host, virus and cellular factors.;Secondary Objective: Secondary Objectives: - To assess the incidence and severity of side effects of imiquimod therapy, compared to LLETZ treatment. - To assess cytological disease recurrence at 6, 12 and 24 months follow-up, for both treatment groups. - To assess Quality of life (QoL) before, during and after treatment for both treatment groups. ;Primary end point(s): 1. Regression-or-not of CIN2 or CIN 3 lesions after imiquimod therapy defined as regression to CIN 1 or less, at 20 weeks follow-up and adequate treatment of high-grade CIN by LLETZ, defined as no need for additional treatment within 6 months. 2. A prediction model for treatment efficacy of imiquimod in the individual patient, based on biomarkers reflecting host, virus and cellular factors.;Timepoint(s) of evaluation of this end point: 1. imiquimod: 20 weeks; LLETZ: 6 months 2. not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Side effects of imiquimod therapy and LLETZ therapy as scored by the Common Terminology Criteria for Adverse Events guidelines. 2. Disease recurrence at 6, 12 and 24 months follow-up, defined as abnormal cervical cytology for all treatment roups. 3. Quality of life (QoL) before, during and after treatment, assessed by the following QoL questionnaires at 0 and 20 weeks and after 1 year: a. Medical Outcomes Study 36-Item Short-Form General Health Survey (RAND 36), to assess generic health-related quality of life b. European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-C30, to assess cancer-specific health-related quality of life c. European Organization for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire: QLQ-CX24, to assess cervical cancer specific quality of life, including sexual functioning;Timepoint(s) of evaluation of this end point: 1. imiquimod: 20 weeks; LLETZ: 6 weeks 2. 6, 12 and 24 months 3. 0, 20 and 52 weeks | — |
Countries
Netherlands
Contacts
Public ContactDr. M. Weemhoff, MD
Zuyderland MC
Outcome results
None listed